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LOL, I'm ready to see Durrant doing burnouts in the parking lot with Chappell's stolen Ferrari and maybe Noomis will bring the Jetski's for spin!
I'm excited about next week, but I also am being reasonable so instead of a Ferrari it could Dale's White 98 VW Jetta, either way let's see some smoke!
Ha ha, personally I have been really busy with things but I am holding very strong. Next week is a big one for us and I can't wait for it to get started.
Light volume today but would not be surprised at all to see some big chunks right at the close today.
Nice!! Looking forward to progress updates.
I'd like to see HGEN be part of something like the 2019's 5 Things to know from the JP Morgan
https://www.ajmc.com/view/5-things-to-know-from-the-jp-morgan-healthcare-conference
Phew, just getting caught back up on the action for the last week, and I'm fine with the offering as it does what you are stating Jay. HGEN in on the cusp of EUA & more importantly BLA for Lenzilumab that opens doors for National Stockpile and uses outside of Covid. I'll keep reading and see what else I find, but at the moment I'm positive about the situation. I am a big fan of what's happening with the company, but my trust only runs so deep for any of them.
Updated : ACTIV-5 / Big Effect Trial (BET-B) for the Treatment of COVID-19
More sites opened/added. Estimated completion date still reported as January 8, 2021.
https://clinicaltrials.gov/ct2/history/NCT04583969?A=8&B=9&C=Side-by-Side#StudyPageTop
Is it Tuesday yet? Let's get this train back on the tracks. Maybe if the MAB factory burns down we can see $20's again !! I'm no scientist, but when The Mayo Clinic says we're good, I trust'em. Big Show starts in January and I'll be strapped in.
"This patent underscores Humanigen’s pioneering approach to neutralizing GM-CSF with lenzilumab and the value of our robust pipeline across the many disease areas where cytokine storm plays a critical role, including COVID-19 and acute graft-versus-host disease."
Yes, January is going to be a very busy month for HGEN. Looking forward to all of the upcoming news and catalyst's!
Excellent news!
Awesome, a well deserved reward!
Outcomes of COVID-19 With the Mayo Clinic Model of Care and
Research
https://www.mayoclinicproceedings.org/covid-19
PDF Article is titled: Outcomes of COVID-19 With the Mayo Clinic Model of Care and Research
Collaborative Mayo Clinic Model of Care leads to favorable outcomes for patients with COVID-19
Yeah Nomis, and we expect an invite to come over and ride the Jet Ski's this summer as well.
Thank you in advance,
Knuckle Sandwich
Mayo Clinic Model of Care and Research leads to favorable outcomes for patients with COVID-19
by Jay Furst, Mayo Clinic
Patients with COVID-19 who received care at Mayo Clinic, whether in the hospital or at home, had outcomes that compared favorably to those reported nationally and internationally. These results demonstrate the value of an integrated, team-based approach to patient care and monitoring, according to a retrospective study of all patients with COVID-19 treated at Mayo Clinic March 1-July 31.
Included in the research during the study period were 7,891 patients who tested positive for COVID-19 and were treated at Mayo Clinic. Of those patients, 897 required hospitalization—354 in an ICU. An intensive, multilayered approach was used to manage patient care, leveraging clinical trials and available therapies, and using remote monitoring tools for patients before or after hospital care.
Just over 77.5% of hospitalized patients received at least one COVID-19 therapy, such as an antiviral drug, systemic steroid, immunomodulatory monoclonal antibody or convalescent plasma. Nearly one-quarter of hospitalized patients received two therapies, most commonly a combination of steroids and antiviral medications.
The research, published in Mayo Clinic Proceedings, finds that mortality rates were lower than the national and international averages, and lower than what has been reported in other major studies and expanded-access programs. An overall mortality rate of 1.1% was reported for patients treated at Mayo, with inpatient mortality of 7.1% and ICU mortality of 11.9%.
"COVID-19 patients treated at Mayo Clinic were diagnosed, monitored and treated with a team- based approach that was designed to ensure that all patients were treated with the most up-to-date, evidence-based, treatments available," says Andrew Badley, M.D., chair of Mayo Clinic's COVID-19 Research Task Force. "By including subject matter experts from a range of disciplines in our treatment teams, and having those treatment teams reviewing the care and progress of each patient daily, our outcomes were better than what had previously been reported."
Most patients who were cared for at Mayo Clinic were not part of the first wave of infections. "Mayo physicians and scientists were able to learn from the experience of other hospitals and adopt the best practices learned into our treatment paradigms," Dr. Badley says. "That knowledge, together with the increased access to experimental agents, is likely the major reason for the outcomes we observed."
Most cases occurred June 1-July 31, accounting for 87.5% of total cases during the study period. Mayo Clinic locations across the Upper Midwest saw 59% of patients with COVID-19, with Mayo Clinic in Arizona seeing 23% and Mayo Clinic in Florida seeing 18%. Of the patients treated, 674 were under 18. Only 13 pediatric patients were admitted to the hospital, and no deaths were reported. Given the low rates of complications, pediatric patients were excluded from subsequent analyses.
Credit: Mayo Clinic
Among the 7,217 adults included in the analysis, 87.6% did not require hospitalization. Of these outpatients, 30 died, primarily in hospice or skilled nursing facilities. The median age of adult patients treated at Mayo was 59. There were slightly more male patients than female patients, and male patients were more likely to require hospitalization. The most common comorbidities were chronic obstructive pulmonary disease, 11.8%; diabetes, 9.4%; renal disease, 6.5%; and peripheral vascular disease, 6.2%.
The article notes that COVID-19 mortality rates have declined as the pandemic has progressed, with one possible factor being that testing initially was prioritized for those with specific symptoms and later expanded to asymptomatic people. "The support offered by Mayo Clinic labs to allow us to start aggressive testing was critical to these outcomes," says John O'Horo, M.D., a Mayo Clinic infectious diseases physician and the study's first author. "We were able to stand up drive-thru and hospital testing quickly, identify COVID-19 patients earlier, and initiate care in a more timely manner than would have otherwise been possible."
Another factor contributing to these favorable outcomes was Mayo Clinic's outpatient COVID-19 management teams and its remote monitoring capabilities, says Dr. Badley. These programs allow for high-risk patients to be monitored at home, and detect complications or clinical deterioration early, so that hospital admission and advanced care can be provided in a timely manner. "The high proportion of our patients who were able to participate in these programs was likely a contributor to our outcomes," he says.
Another possible contributor to improved outcomes was the growing acceptance of masks and social distancing, which reduce exposure and potentially reduce the severity of illness.
Mayo Clinic has been a leader in caring for, researching and testing patients with COVID-19 since the pandemic began, with teams developing experimental therapies and clinical trials. Mayo Clinic Laboratories has developed highly accurate diagnostic and antibody tests for COVID-19, and has performed more than 2 million molecular tests for patients. Mayo Clinic was the lead institution for the national Expanded Access Program for Convalescent Plasma, which led to emergency authorization for the use of plasma to help critically ill patients.
As the pandemic continues to surge in many parts of the country, Dr. Badley says the lessons learned by Mayo Clinic and other health care providers in the early phase continue to guide patient care and research going forward.
"The volume of patients that we now are seeing in the Midwest and nationally is vastly greater than it was last spring and summer, but all of the processes that we have put in place and have optimized are continuing," Dr. Badley says. "As this global pandemic approaches its first anniversary, we should be heartened by the advances that have been made in testing, diagnosis and management of COVID-19 and its complications. By adopting best practices learned from all institutions, we can continue to improve outcomes for patients."
Lenzilumab Demonstrates Clinical Benefit in Patients With Chronic Myelomonocytic Leukemia
WEDNESDAY, JULY 1, 2020
A phase I study found that lenzilumab, an engineered human IgG1K monoclonal antibody that neutralizes granulocyte-macrophage colony-stimulating factor (GM-CSF), was associated with a clinical benefit in approximately one-third of patients with chronic myelomonocytic leukemia (CMML). The study results, published in Blood, suggested this novel antibody has some activity in what is an aggressive hematologic neoplasm with limited therapeutic options and where cellular GM-CSF hypersensitivity is common.
This phase I clinical trial enrolled 15 patients who were refractory to, intolerant of, or ineligible for hypomethylating agents (HMAs) or hydroxyurea therapy. The purpose of the study, as for most phase I trials, was to evaluate safety and identify the recommended phase II dose of lenzilumab in this patient population.
The investigators studied 3 dose levels: 200 mg, 400 mg, and 600 mg. Each treatment dose was intravenously administered on days 1 and 15 of cycle 1, then on day 1 of subsequent 28-day cycles. Three patients were assigned to the 200- and 400-mg dose levels, and 9 patients were enrolled in the 600-mg dose group.
Responses to therapy were assessed with the Myelodysplastic Syndromes/Myeloproliferative Neoplasm International Working Group (IWG-MDS/MPN) response criteria, which were published in Blood in 2015.
Approximately 20% of patients enrolled in the trial were treatment-naïve, whereas 60% (n=9) had previously received an HMA and/or experimental therapies, and 20% (n=3) were previously treated with hydroxyurea. The median age at baseline was 74 years (range = 52-85), and the majority of patients (80%) were men. Patients were classified based on their CMML subtype:
CMML-0 (n=9): the presence of <2% blasts in blood and <5% blasts in bone marrow
CMML-1 (n=3): the presence of 2-4% blasts in blood and/or 5-9% blasts in bone marrow
CMML-2 (n=3): the presence of 5-19% blasts in blood and/or 10-19% blasts in bone marrow
Most (11/15, 73%) enrolled patients had normal cytogenetics. At screening, the most frequently observed mutated genes were TET2 (60%), ASXL1 (53%), SRSF2 (47%), and RAS pathway (NRAS or CBL) mutations (40%). At enrollment, the median hemoglobin level was 9.7 g/dL (range = 7.6-14 g/dL), and the median white blood cell count was 10×109/L (range = 5.3-59.8 ×109/L). The median absolute monocyte count was 4.5×109/L (range = 1.3-10×109/L), the median platelet count was 147×109/L (range = 16-942×109/L), and approximately 66% of patients had MPN-type CMML (WBC >13×109/L) at screening.
There were no dose-limiting toxicities or treatment-emergent toxicities associated with any of the treatment doses, and the investigators observed no study drug-related or grade 3 or 4 toxicities in any group. A total of 2 patients in each group had grade 3 neutropenia, whereas 1 patient in each group had grade 4 neutropenia; these were not deemed to be related to the study drug. Grade 2 anemia and neutropenia were reported in 1 patient in each group.
“Given the lack of toxicity and modest efficacy, future research will focus on identifying combination therapies that include lenzilumab or other GM-CSF inhibitors.”
—Eric Padron, MD
The median duration of therapy was 110 days (range = 14-798). A total of 4 patients (27%) achieved a clinical benefit based on IWG-MDS/MPN criteria, including 3 platelet responses and 1 neutrophil response. The median duration of best response was 5.5 months (range = 1-14). In addition, 1 patient who experienced a reduction in bone marrow myeloblasts from 6% to 1% underwent an allogeneic hematopoietic cell transplantation.
Three of the 5 responding patients and 1 of the nonresponding patients had NRAS mutations. According to the authors, this finding may be “consistent with prior reports suggesting that GM-CSF hypersensitivity in CMML is more prominent in patients with RAS pathway mutations.”
The researchers also performed progenitor colony forming assays in 3 patients, including 1 responder who had an NRAS mutation and 2 nonresponders with NRAS wild type. In this subset of patients, the researchers observed a noticeable GM-CSF hypersensitivity in the responding patient compared with the nonresponders.
According to corresponding study author Eric Padron, MD, of the Moffitt Cancer Center in Tampa, Florida, this is the first study that evaluated neutralization of GM-CSF as a therapeutic strategy in CMML. “Given the lack of toxicity and modest efficacy,” he said, “future research will focus on identifying combination therapies that include lenzilumab or other GM-CSF inhibitors.” Dr. Padron added that further studies are needed to investigate the efficacy and safety of lenzilumab in pediatric patients with juvenile myelomonocytic leukemia, who also have GM-CSF hypersensitivity.
Limitations of this trial include its small sample size and lack of a control group.
The authors report no relevant conflicts of interest.
Reference
Patnaik MM, Sallman DA, Mangaonkar A, et al. Phase 1 study of lenzilumab, a recombinant anti-human GM-CSF antibody, for chronic myelomonocytic leukemia (CMML). Blood. 2020 Apr 15. [Epub ahead of print]
Lenzilumab as a Treatment for Chronic Myelomonocytic Leukemia
KENDALL MASON
July 7, 2020
Chronic myelomonocytic leukemia, Rare Disease
According to ASH Clinical News, a phase 1 trial of lenzilumab illustrated clinical benefits for approximately one third of participants with chronic myelomonocytic leukemia. It is a novel antibody, and according to study results published in Blood, it has some activity with “limited therapeutic options.”
About Chronic Myelomonocytic Leukemia (CMML)
CMML is a cancer that begins in the blood-forming cells within bone marrow and then moves on to the blood. The issue becomes a surplus of monocytes, which then heightens the total white blood cell count. Affected individuals also face a 15-30% chance of developing acute myeloid leukemia. Doctors will usually diagnose this cancer after they notice the characteristic symptoms, which include an enlarged spleen, pain in the abdomen, and a feeling of fullness. Those with CMML may also experience loss of appetite, fever, and weight loss. After a diagnosis, there are multiple treatment options for patients. These are chemotherapy, radiation, surgery, stem cell transplants, growth factors, and supportive therapy.
About the Study
The first phase of this trial included 15 patients with CMML that either did not respond to or was ineligible for hydroxyurea therapy and hypomethylating agents. Researchers’ aim was to discover the correct dosage and test the safety of lenzilumab.
Participants were separated into three dosages: 200 mg, 400 mg, and 600 mg. The therapy was administered through an IV on day one and day 15, and then every 28 days after. Using the Myelodysplastic Syndromes/Myeloproliferative Neoplasm International Working Group response criteria, researchers were able to assess lenzilumab.
In terms of results, none of the dosages saw dose limiting or treatment emergent toxicities. After 110 days of treatment, 27% of participants achieved a clinical benefit. The median time to response was 5.5 months.
It is these results, along with the lack of toxicity, that encourage researchers to move forward with lenzilumab as a treatment for CMML. They also plan to test this therapy in children with juvenile CMML.
Imagine trying to just get 30% of population vaccinated from a logistics standpoint, and population acceptance, and then couple that with a 2 course shot over 6 weeks, and then lining backup and doing it all over again in 6 months. Absolute mess! What kind of impact would that continue to have on schools, economies, and quality of life.
Yes, much much more focus should be applied to therapeutics here. We still aren't sure how long the Vaccine lasts once administered, some have said 3 months. CDC doesn't know yet.
Definitely much better value for HGEN as well as a capable leadership team in place for the Government to risk partnering with a small company like HGEN. They will deliver when BARDA is ready to take the next step. I'd give Cameron my ATM card an PIN # and not think twice about it. What's he gonna do with $17 bucks anyway!
Got my popcorn ready, it's time for the show! HGEN let's Go!
For now !! LOL, I think previous was $34 from HC Wainwright Analysis Joseph Pantginis
https://www.tipranks.com/stocks/hgen/forecast
COVID-19
Cases are rising. Act now! Wear a mask; Stay 6 feet apart; Avoid crowds.
YOUR HEALTH
Facts about Vaccination
Updated Dec. 20, 2020
Now that there are authorized and recommended COVID-19 vaccines in the United States, accurate vaccine information is critical.
FACT: COVID-19 vaccines will not give you COVID-19
None of the COVID-19 vaccines currently in development or in use in the United States, contain the live virus that causes COVID-19. There are several different types of vaccines in development. However, the goal for each of them is to teach our immune systems how to recognize and fight the virus that causes COVID-19. Sometimes this process can cause symptoms, such as fever. These symptoms are normal and are a sign that the body is building immunity. Learn more about how COVID-19 vaccines work.
It typically takes a few weeks for the body to build immunity after vaccination. That means it’s possible a person could be infected with the virus that causes COVID-19 just before or just after vaccination and get sick. This is because the vaccine has not had enough time to provide protection.
FACT: COVID-19 vaccines will not cause you to test positive on COVID-19 viral tests
Neither the recently authorized and recommended vaccines nor the other COVID-19 vaccines currently in clinical trials in the United States cause you to test positive on viral tests, which are used to see if you have a current infection.?
If your body develops an immune response, which is the goal of vaccination, there is a possibility you may test positive on some antibody tests. Antibody tests indicate you had a previous infection and that you may have some level of protection against the virus. Experts are currently looking at how COVID-19 vaccination may affect antibody testing results.
FACT: People who have gotten sick with COVID-19 may still benefit from getting vaccinated
Due to the severe health risks associated with COVID-19 and the fact that re-infection with COVID-19 is possible, people may be advised to get a COVID-19 vaccine even if they have been sick with COVID-19 before.
At this time, experts do not know how long someone is protected from getting sick again after recovering from COVID-19. The immunity someone gains from having an infection, called natural immunity, varies from person to person. Some early evidence suggests natural immunity may not last very long.
We won’t know how long immunity produced by vaccination lasts until we have a vaccine and more data on how well it works.
Both natural immunity and vaccine-induced immunity are important aspects of COVID-19 that experts are trying to learn more about, and CDC will keep the public informed as new evidence becomes available.
Indeed it was. Looking for to January fireworks here
Fantastic! Another solid close here.
We are definitely rolling with the Barry Sanders of that group. Durrant isn't going to be impressed or self pumping when he knows there is still allot of work to do. Barry Sanders didn't dance all over the endzone patting himself on the back and doing the Douggie. Instead Barry acted with class, he acted like he'd been there before and would be back again. Durrant definitely has that same quality about his approach. The biggest difference would be the Lions had no help around Barry, while Durrant has surrounded himself with a talented group of Industry Veterans.
Paying attention to their words, and watching them continue to deliver on promises has made me confident in the future, and never once shook me while my shares were down. Only regret I have is not having enough cash to keep loading as I would have continued to do just that. I know where we are headed here.
Humanigen Australia Proprietary Limited Established to Facilitate Asia-Pacific Growth Plans
New Humanigen entity in Australia creates focused opportunity for partnering, regional clinical trials and market access
Structure allows for attractive financial incentives supported by the Australian government
November 23, 2020 04:05 PM Eastern Standard Time
BURLINGAME, Calif.--(BUSINESS WIRE)--Humanigen, Inc. (NASDAQ: HGEN) (“Humanigen”), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate, lenzilumab™, today announced the establishment of Humanigen Australia Proprietary Limited (“Humanigen Australia Pty Ltd”), through which Humanigen intends to assess potential partnering opportunities, facilitate clinical development programs, and conduct other corporate and business development activities in the Asia-Pacific region. The first of these was announced on November 3, with the execution of a licensing agreement for lenzilumab for South Korea and the Philippines.
The clinical trials that are ongoing, or in advanced planning in Australia are:
Lenzilumab in cancer patients who are COVID-19 positive and have pneumonia as part of the C-SMART (COVID-19 Prevention and Treatment in Cancer; a Sequential Multiple Assignment Randomized Trial)
The C-SMART study is led by the National Centre for Infections in Cancer at Peter MacCallum Cancer Centre and will be conducted at five Australian sites in Melbourne and Sydney. This study will include over 1,000 cancer patients at risk of, or known positive for, COVID-19 infection, with a subset of patients in the lenzilumab arm. The study is supported by a grant from the Australian Government's Medical Research Future Fund.
Lenzilumab in refractory chronic myelomonocytic leukemia (CMML) as part of the PREcision Approach to CHronic Myelomonocytic Leukaemia (PREACH-M) trial
Humanigen is in advanced planning for a Phase 2 study of lenzilumab in combination with azacitidine in newly-diagnosed CMML patients who express NRAS/KRAS/CBL mutations, which are known to be hypersensitive to granulocyte macrophage-colony stimulating factor (GM-CSF) and therefore may lend themselves to responsiveness to lenzilumab treatment. CMML is a rare form of hematologic cancer with no FDA-approved treatment options and a three-year overall survival rate of 20% and median overall survival of 20 months.1,2 The study is funded by grant from the Australian Government's Medical Research Future Fund and is expected to commence in 2021.
Ifabotuzumab in glioblastoma multiforme (GBM)
This Phase 1 trial has enrolled 11 of the 12 patients targeted for full enrollment. Results are expected to be available in the first half of 2021.
Professor Andrew Scott, Head, Tumour Targeting Laboratory, Olivia Newton-John Cancer Research Institute, and Professor, School of Cancer Medicine, La Trobe University, who has been instrumental in the research and development of both lenzilumab and ifabotuzumab, said, "The establishment of Humanigen Australia Pty Ltd speaks to the importance and culmination of 20 years of research for these two novel antibodies, which we helped discover and develop in Australia. We hope that lenzilumab will have a major impact in the treatment of COVID-19 patients. Ifabotuzumab holds promise as a novel approach to target the tumour microenvironment in a range of solid tumors."
Bob Atwill, Head of Asia-Pacific Region at Humanigen said, “Humanigen’s expansion strategy in COVID-19 includes conducting regional clinical trials, local manufacturing, partnering and potential early market entry. Some of these opportunities may allow Humanigen Australia Pty Ltd to benefit from certain financial and tax incentives offered by the Australian government, including a potential 43.5% rebate on eligible research and development expenditures. This is a critical moment for important advancements in biotechnology and healthcare, and I look forward to progressing lenzilumab and the rest of the Company’s pipeline in the Asia-Pacific region as we grow Humanigen Australia Pty Ltd.”
About Humanigen, Inc.
Humanigen, Inc. is developing its portfolio of clinical and pre-clinical therapies for the treatment of cancers and infectious diseases via its novel, cutting-edge GM-CSF neutralization and gene-knockout platforms. We believe that our GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with coronavirus infection. The company’s immediate focus is to prevent or minimize the cytokine release syndrome that precedes severe lung dysfunction and ARDS in serious cases of SARS-CoV-2 infection. The company is also focused on creating next-generation combinatory gene-edited CAR-T therapies using strategies to improve efficacy while employing GM-CSF gene knockout technologies to control toxicity. In addition, the company is developing its own portfolio of proprietary first-in-class EphA3-CAR-T for various solid cancers and EMR1-CAR-T for various eosinophilic disorders. The company is also exploring the effectiveness of its GM-CSF neutralization technologies (either through the use of lenzilumab as a neutralizing antibody or through GM-CSF gene knockout) in combination with other CAR-T, bispecific or natural killer (NK) T cell engaging immunotherapy treatments to break the efficacy/toxicity linkage, including to prevent and/or treat graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). Additionally, Humanigen and Kite, a Gilead Company, are evaluating lenzilumab in combination with Yescarta® (axicabtagene ciloleucel) in patients with relapsed or refractory large B-cell lymphoma in a clinical collaboration. For more information, visit www.humanigen.com.
Forward-Looking Statements
This release contains forward-looking statements. Forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual events or results may differ materially from those contained in the forward-looking statements. Words such as "will," "expect," "intend," "plan," "potential," "possible," "goals," "accelerate," "continue," and similar expressions identify forward-looking statements, including, without limitation, statements regarding our expectations surrounding our operational, research, development or commercialization activities in the Asia Pacific region, and our ability to mitigate the impact of COVID-19, to develop CAR-T or solid cancer therapies or to prevent or treat GvHD via any of the technologies in our current pipeline. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in our lack of profitability and need for additional capital to conduct the Phase III study and grow our business; our dependence on partners to further the development of our product candidates; the uncertainties inherent in the development, attainment of the requisite regulatory approvals and launch of any new pharmaceutical product; the outcome of pending or future litigation; and the various risks and uncertainties described in the "Risk Factors" sections and elsewhere in the Company's periodic and other filings with the Securities and Exchange Commission.
All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not place undue reliance on any forward-looking statements, which speak only as of the date of this release. We undertake no obligation to revise or update any forward-looking statements made in this press release to reflect events or circumstances after the date hereof or to reflect new information or the occurrence of unanticipated events, except as required by law.
1. Patnaik MM, Tefferi A. Chronic Myelomonocytic leukemia: 2020 update on diagnosis, risk stratification and management. Am J Hematol. Jan 2020;95(1):97-115. doi:10.1002/ajh.25684
2. Coston T, Pophali P, Vallapureddy R, et al. Suboptimal response rates to hypomethylating agent therapy in chronic myelomonocytic leukemia; a single institutional study of 121 patients. Am J Hematol. Jul 2019;94(7):767-779. doi:10.1002/ajh.25488
Contacts
Media
Cammy Duong
Westwicke, an ICR company
Cammy.duong@westwicke.com
203-682-8380
Investors
Alan Lada
Solebury Trout
ALada@SoleburyTrout.com
617-221-8006
The total number of study patients seems like a large at 2,282 / 4 Arms = 570 per Arm. It is a Phase III study, and I assume it will be more weighted with a larger number of patients on the front end with Prophylaxis patients. The confidence in allowing Lenzilumab to be the only choice for Severe in such a High Risk Patient I see as huge endorsement of what they believe Lenz is capable of. Australia is very familiar with Lenzilumab as it started there and there are certain benefits from Australian Government.
Bob Atwill, Head of Asia-Pacific Region at Humanigen said, “Humanigen’s expansion strategy in COVID-19 includes conducting regional clinical trials, local manufacturing, partnering and potential early market entry. Some of these opportunities may allow Humanigen Australia Pty Ltd to benefit from certain financial and tax incentives offered by the Australian government, including a potential 43.5% rebate on eligible research and development expenditures. This is a critical moment for important advancements in biotechnology and healthcare, and I look forward to progressing lenzilumab and the rest of the Company’s pipeline in the Asia-Pacific region as we grow Humanigen Australia Pty Ltd.”
Great analogy Engineer. We have seen this game, and it doesn't phase me one bit.
The Lenzilumab Arm is the only Arm selected for treating Severe COVID-19 infection. There other 3 Arms are Prophylaxis, Post-Exposure Prophylaxis and Moderate. The study estimated completion is 12/2021 but I assume results will be provided as each individual arm is completed? I think the fact that Lenz was singled out as the therapeutic for Severe shows allot of confidence in what the potential is especially with a highly vulnerable patient population.
Experimental: Severe COVID-19 infection
This study arm (arm 4) is evaluating the effect of Lenzilumab on the treatment of COVID-19 infection in cancer patients with severe COVID-19 infection.
Participants in this study arm are randomly allocated (by chance) to one of two groups. One group will receive intravenous Lenzilumab over 24 hours while the other group will receive placebo intravenously over 24 hours.
Participants will be followed for 60 days to assess effectiveness and safety.
The more the merrier, I'd love to see that Wells Fargo Stagecoach pull up and drop a Big #. Yee Haw!!
Yes, I agree that they are posting a very conservative target. Under promising and over delivering seems to be the mantra.
Even at $50 which I think is conservative based on the doors HGEN will be opening in 2021 the Market Cap would only be above $2.5 Billion.
There is allot of room for growth here.
2021 alone will bring EUA & BLA for Lenzilumab with BARDA & OWS support is huge. The BLA here allows Lenzilumab to also go to work in Non-Covid ARDS which is a recurring issue.
Updated Car-T Data with Kite/Gilead Collaboration in Yescarta where a victory here directly links HGEN to Novartis Kymriah.
Ifabotuzumab data in Glioblastoma which is really exciting since it is possible they are directly attacking the tumors without damaging healthy brain cells.
GVHD Trail with Impact Group and University of Zurich.
Phase II in CMML is already in advanced planning. Phase I was with Mayo Clinic and Moffitt Cancer Centers
Eosinophilic Asthma (EA) - Phase II is already completed and they are seeking partners for a Phase III
Additional unexpected income from treating Covid-19 should open the opportunity for more studies rolling out sooner. Management is a group of seasoned & accomplished Big Pharma veteran's who know how to handle this journey, and they may decide to keep swinging for the fences or a Big Boy might just swoop in and write the check. Who knows, but either way it is going to be a special journey. A buyout takes the risk away, but I am also interested to see what they can accomplish as a small team without all the excess corporate bullshit getting in the way.
https://www.humanigen.com/pipeline
WOW! This is a very telling find. The future is looking very bright for Lenzilumab & HGEN. Looking forward to beating down this virus for good, and along with Vaccines people need to Therapeutics like Lenzilumab that can get the job done.
COVID-19 Prevention and Treatment in Cancer; a Sequential Multiple Assignment Randomised Trial; (C-SMART)
Trial updated today to Active & Recruiting. This is a very interesting study as it is comparing therapies in Covid-19 Patients with Cancer.
Brief Summary:
A multi-centre Australian trial with four arms aims to evaluate several different immune modulating drugs for prevention and treatment of COVID-19 specifically in the cancer population.
ARM 1 is evaluating the effect of interferon-alpha (vs placebo) on the incidence of COVID-19 infection in cancer patients with no COVID-19 infection or no known COVID-19 positive contacts.
ARM 2 is evaluating the effect of interferon-alpha (vs placebo) on the incidence of COVID-19 infection in cancer patients with confirmed exposure to COVID-19 virus.
ARM 3 is evaluating the effect of Selinexor (vs placebo) on the incidence of COVID-19 infection in cancer patients with moderate COVID-19 infection.
ARM 4 is evaluating the effect of Lenzilumab (vs placebo) on the treatment of COVID-19 infection in cancer patients with severe COVID-19 infection.
Participants may become eligible and transition to different arms and treatments if they become exposed to COVID-19 or are hospitalised with an active moderate/severe COVID-19 infection.
It is hoped this research will provide insight into the best practice for prevention and treatment of COVID-19 in cancer patients as emerging standard of care measures are not always suitable to this especially vulnerable population.
Tip Ranks Analyst Forecasts for HGEN
https://www.tipranks.com/stocks/hgen/forecast
I think I saw Durranta Claus do a flyby. HGEN just keeps delivering on exactly what he has told shareholders. Things are getting exciting for sure.
Nice, we now have 5 analysts covering us with Jeffries joining.
BRYAN, GARNIER & CO Olga Smolentseva
HC WAINWRIGHT Joe Pantginis
ROTH CAPITAL PARTNERS Tony Butler
CANTOR FITZGERALD Louise Chen
JEFFRIES Biren Amin
Highlighted sections from HGEN Company Website under Lenzilumab Development Page as well as the National Health Security Strategy 2019-2022.
I believe that The National Stockpile portion of Lenzilumab's EUA & Subsequent BLA are a very important part of future sales in maintaining stockpile reserves.
With data from the BET and our ongoing Phase III study, including the component being conducted in Brazil, we expect to have data from approximately 500 hospitalized COVID-19 patients.
We believe that the ongoing Phase III study has the potential to serve as a basis for lenzilumab to receive EUA from FDA. The FDA’s authority to grant EUAs emanates from the Pandemic and All Hazards Preparedness Reauthorization Act of 2013, which authorizes and enhances FDA’s ability to support emergency preparedness and foster the development and availability of medicinal products (drugs, biologics and medical devices) for use in emergencies. EUAs permit marketing and use of medicinal products in response to declared, public health emergencies before the products are approved by FDA under the Food, Drug, & Cosmetic Act. FDA, however, holds authority to limit, restrict or condition the amount of promotional activity that accompanies EUA-approved medicinal products. An EUA, if issued in respect of lenzilumab, would be temporary; if an EUA were issued, that would not take the place of our need to complete the formal BLA submission, review and approval process.
2. Protect the nation from the health effects of emerging and pandemic infectious diseases and
chemical, biological, radiological, and nuclear (CBRN) threats.
Areas of focus for this objective include, but are not limited to:
• Continuing efforts to improve early detection of emerging and potential pandemic
infectious diseases;
• Rapidly identifying, developing, producing, and making available safe, effective medical
countermeasures (MCMs)ii
ii Medical Countermeasures are pharmaceutical products, such as vaccines, antimicrobials, and antitoxins, and
nonpharmaceutical products, such as ventilators, diagnostic tests, PPE, and patient decontamination materials,
that may be used to prevent, mitigate, or treat the adverse health effects from a public health emergency.
;
• Maintaining the capacity to produce enough vaccines and other necessary MCMs to
provide protection from pandemic influenza and CBRN agents that represent a strategic
health security threat to the nation; and
• Supporting SLTT authorities’ efforts to stock, and rapidly obtain, distribute, dispense,
administer, and monitor the safety of MCMs.
CART Cell Toxicities: New Insight into Mechanisms and Management
Authors
Anas Zahid1, ORCID, Elizabeth L. Siegler2, 3, Saad S. Kenderian2, 3, 4, 5, *, ORCID
1
College of Medicine, Mohammed Bin Rashid University of Medicine and Health Sciences, Dubai, U.A.E
2
T Cell Engineering, Mayo Clinic, Rochester, MN, USA
3
Division of Hematology, Mayo Clinic, Rochester, MN, USA
4
Department of Immunology, Mayo Clinic, Rochester, MN, USA
5
Department of Molecular Medicine, Mayo Clinic, Rochester, MN, USA
*
Corresponding author. Email: Kenderian.saad@mayo.edu
Corresponding Author
Saad S. Kenderian
Received 4 September 2020, Accepted 22 October 2020, Available Online 23 November 2020.
Abstract
T cells genetically engineered with chimeric antigen receptors (CART) have become a potent class of cancer immunotherapeutics. Numerous clinical trials of CART cells have revealed remarkable remission rates in patients with relapsed or refractory hematologic malignancies. Despite recent clinical success, CART cell therapy has also led to significant morbidity and occasional mortality from associated toxicities. Cytokine release syndrome (CRS) and Immune effector cell-associated neurotoxicity syndrome (ICANS) present barriers to the extensive use of CART cell therapy in the clinic. CRS can lead to fever, hypoxia, hypotension, coagulopathies, and multiorgan failure, and ICANS can result in cognitive dysfunction, seizures, and cerebral edema. The mechanisms of CRS and ICANS are becoming clearer, but many aspects remain unknown. Disease type and burden, peak serum CART cell levels, CART cell dose, CAR structure, elevated pro-inflammatory cytokines, and activated myeloid and endothelial cells all contribute to CART cell toxicity. Current guidelines for the management of toxicities associated with CART cell therapy vary between clinics, but are typically comprised of supportive care and treatment with corticosteroids or tocilizumab, depending on the severity of the symptoms. Acquiring a deeper understanding of CART cell toxicities and developing new management and prevention strategies are ongoing. In this review, we present findings in the mechanisms and management of CART cell toxicities.
Copyright
© 2020 International Academy for Clinical Hematology. Publishing services by Atlantis Press International B.V.
7.1. Cytokine-directed therapy: IL-6, IL-1, GM-CSF
IL-6 is associated with severe CRS after CART cell therapy, and tocilizumab, a monoclonal antibody against IL-6R, was approved by the FDA for the management of CRS [50]. Tocilizumab had originally been used to treat rheumatoid and juvenile arthritis but has also shown effectiveness in reducing CRS-associated symptoms after the infusion of CART cells [18]. The dosage suggested by the FDA is 8 mg/kg for adult patients and 12 mg/kg for patients who have a weight lower than 30 kg.
Recent studies suggest that IL-1, produced by activated macrophages, plays a key part in eliciting CRS and ICANS. Anakinra, an IL-1 antagonist which is clinically available but not yet FDA approved for CART-associated toxicities, may lessen both CRS and ICANS after CART cell therapy [51,52]. Anakinra reduces the effect of IL-1a and IL-1ß by competing for IL-1R binding and, in the clinic, 1–2 mg/kg/day is administered via subcutaneous injection [53]. Anakinra was able to effectively mitigate CRS and ICANS while maintaining CART cell antitumor efficacy in preclinical studies [50,53,54]. A recent clinical study showed promising results regarding the use of anakinra to alleviate CART-associated toxicities in large B-cell lymphoma [55]. Results from a phase I anti-CD22 CART cell trial showed that anakinra was associated with favorable outcomes when used in patients who developed hemophagocytic lymphohistiocytosis-like manifestations [56]. The ongoing clinical trials exploring the use of anakinra (NCT04432506, NCT04359784, NCT04148430, and NCT04205838), may show additional promising outcomes.
Granulocyte-macrophage colony-stimulating factor (GM-CSF) is produced by activated CART cells and stimulates myeloid cells, suggesting a role in CRS development. IL-6, a major cytokine implicated in CRS, is produced by tumor-resident myeloid cells, which are dependent on GM-CSF [57]. The Rosenberg group revealed that GM-CSF levels are highest during the initial phases of CRS [58]. Moreover, excess GM-CSF can cause ICANS and cerebral edema [59]. Initial GM-CSF surges are linked to more severe CRS [60]. A study conducted by Sterner et al. showed that neutralization of GM-CSF with lenzilumab or with CRISPR gene editing does not prevent antitumor functions of anti-CD19 CART cells in vitro or in vivo. In addition, effective control of leukemia and enhancement of CART cell proliferation was sustained in vivo after GM-CSF neutralization with lenzilumab. In an ALL patient-derived xenograft model of CRS and ICANS, neutralization of GM-CSF led to a decrease in myeloid and T cell infiltration in the central nervous system and a substantial reduction of neuroinflammation and CRS [61]. A study conducted by Sachdeva et al. [62] showed that GM-CSF neutralization with antibodies or with TALEN gene editing in CART cells eliminates macrophage production of CRS-associated cytokines, including IL-6, IL-8, and MCP-1. Anti-GM-CSF therapies have potential to reduce severe adverse effects and improve the safety profile of CART cell therapies while preserving anti-tumor activity.